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ASAHI PTCA GUIDE WIRES are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA GUIDE WIRES are not to be used in the cerebral blood vessels.

Device Description

The ASAHI SION J PTCA Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and there is a safety wire for which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available as a pre shaped "J". A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire.

AI/ML Overview

The submission for the ASAHI SION J PTCA Guide Wire (K122469) primarily relies on demonstrating substantial equivalence to a predicate device (ASAHI SION PTCA Guide Wire - K100578) through characterization of its technical features and performance in bench and biocompatibility testing. The acceptance criteria are essentially that the device performs similarly to or better than the predicate device in these tests, and that its materials are biocompatible, especially given its intended use.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Tensile Strength	Conducted. Meets predetermined criteria. (Specific values not provided in summary)
Torque Strength	"Turns to Failure" (Torque Strength) conducted. Meets predetermined criteria. (Specific values not provided in summary)
Torqueability	"Torque Response" conducted. Meets predetermined criteria. (Specific values not provided in summary)
Tip Flexibility	Conducted. Meets predetermined criteria. (Specific values not provided in summary)
Coating Adhesion	Conducted. Meets predetermined criteria. (Specific values not provided in summary)
Catheter Compatibility	"Slipping Ability of Guide Wire with PTCA Balloon Catheter" conducted. Meets predetermined criteria. (Specific values not provided in summary)
Particulate Testing	Leveraged from the predicate device due to identical product constructions, materials, and manufacturing processes, except for the tip shape. Implies compliance with predicate's performance.
Biocompatibility
Systemic Toxicity	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
In Vitro Hemolysis	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Intracutaneous	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Cytotoxicity	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Sensitization	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Pyrogen	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Plasma Recalcification Time	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Coagulation	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
In Vivo Thromboresistance	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
C3a Complement Activation	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
SC5b-9 Complement Activation	Leveraged from predicate devices with identical materials and manufacturing processes. Implies compliance with predicate's performance.
Overall Conclusion	The ASAHI SION J PTCA Guide Wire meets all predetermined performance criteria and performs as intended. Characteristics are substantially equivalent to specified predicate devices and other currently marketed devices for the same indication for use.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each in vitro bench test or for the biocompatibility leveraging. It broadly states that "Enclosed within this submission is performance data" and "In vitro bench testing...were conducted." For biocompatibility, it states it "was leveraged from the predicate devices."

Therefore:

Sample Size: Not explicitly stated for specific tests.
Data Provenance: The bench testing appears to be prospective testing conducted directly on the ASAHI SION J PTCA Guide Wire. The biocompatibility data is retrospective, leveraged from previously 510(k) cleared Asahi Guide Wire products (predicates). The testing was presumably conducted by Asahi Intecc Co., Ltd. (Japan), but the specific country of origin for the leveraged data is not stated, though the predicate device (K100578) was also from Asahi Intecc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is generally not applicable to a submission for a guide wire, which primarily involves objective engineering and biological tests rather than interpretation by human experts to establish "ground truth" for diagnostic or clinical decision-making. No experts were used in this manner for the described tests.

4. Adjudication method for the test set

Not applicable. The tests described are objective, quantitative/qualitative bench tests and biocompatibility assessments, not subjective assessments requiring adjudication by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical instrument (guide wire), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm or software. Its performance is evaluated through physical and biological testing.

7. The type of ground truth used

The "ground truth" for the performance tests is based on:

Engineering Specifications/Standards: Predetermined performance criteria likely derived from internal specifications, relevant industry standards, or regulatory guidelines for guide wires.
Benchmarking against Predicate: The performance is implicitly compared to the predicate device, where the predicate's established performance acts as a de facto "ground truth" for acceptable levels.
Established Biocompatibility Standards: The biocompatibility evaluations rely on the well-established safety of the materials in previously cleared devices, which have met regulatory biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is a medical instrument, not a machine learning model. There is no concept of a "training set" in its evaluation.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

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